Overview

This course provides an introduction to the science of risk communication for medicinal products, the relevant regulatory context in the US and EU, the basics of risk communication in product risk management, and new directions in the field, including the use of digital and other eHealth methods and patient-centered approaches to risk communication. The course curriculum is directed at basic- through intermediate-level professionals who seek a greater understanding of the vital role of risk communication in medicinal product benefit-risk assessment, risk management and therapeutic treatment decision-making across the product lifecycle. Learning approaches will feature a mix of instructional sessions; real-world case studies; and applied, interactive, individual and small-group learning exercises.

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What you will learn

Gain the ability to evaluate risk communication approaches across the medicinal product lifecycle in light of scientific ‘good practices’ and emerging evidence.
Understand the opportunities for enhancing the effectiveness of safety risk communication in light of evolving regulatory expectations.
Leave with cutting edge, patient-centered solutions for safety risk communication and risk management strategies.

Who should attend?

This program is designed for professionals involved in:

Drug safety and pharmacovigilance, especially safety evaluation and periodic safety reporting
Clinical trial design and operation
Quality systems
Medical writing
Regulatory strategy and regulatory affairs
Regulatory policy
Labeling operations and label development
Risk management plan development, and risk minimization program design, implementation and evaluation (including for formal EU Risk Management Plans and US REMS)
Benefit-risk assessment of medicinal products

Learning objectives

At the conclusion of this course, participants should be able to:

Identify good practices and principles for designing effective risk communication messages and tools
Describe the current regulatory expectations regarding safety risk communication across the medicinal product lifecycle
Recognize the different types of communication challenges associated with medicinal product risks
Demonstrate an awareness of risk communication as an integral component of therapeutic risk management
Discuss the role of implementation in the success of risk communication efforts locally, regionally, and globally
Evaluate risk communication strategies for feasibility, effectiveness, and patient-centeredness
Name key future trends in safety risk communication

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